aids HIV
Conditions
Interventions
The intervention includes DRV/r according to standard clinical practice.
Subjects pre-treated with PIs will receive twice daily DRV/r 600/100 mg.
Subjects not pre-treated with PI will receive once d
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a. Using cART for at least 48 weeks, including 2 NRTIs + 1 NNRTI or 1 PI b. Low level viremia (2 or more HIV viral loads between 50-1000 cp/mL in a year, without Target Not Detected (TND) in between c. Viral load
Exclusion criteria
Exclusion criteria: a. Presence of known pol major IAS mutations for darunavir (I47V; I50V; I54M/L; L76V; I84V) b. Signs of opportunistic infections c. Major suspicion of inadequate therapy adherence d. Severe depression at screening (BDI score >30) e. Severe hepatic impairment (Child-Pugh Class C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with virological response during intervention will be compared to baseline and categorized according to responders (viral load 50 cp/mL at 24 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological markers, neurocognitive performance, periodontal inflammation, HIV resistance associated mutations, HIV genetic variation (RNA and proviral DNA). Genetic compartmentalization of HIV (CSF-plasma and saliva-plasma comparison). | — |
Countries
Netherlands
Outcome results
None listed